A Manager in the Global Regulatory Medical Writing and Submission Management organization at Teva provides basic-level oversight and guidance, as well as resource management, for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation. This role supports the areas of drug development, product registrations, and product marketing. International and domestic travel required and ample opportunity for professional growth! .
Essential Duties & Responsibilities:
- Oversees/Mentors for all document types and offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
- Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
- Provides mentoring and know-how to medical writers preparing any document type
- Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
- Performs quality assurance review of documents and participates in meetings at the document team and clinical sub-team levels
- Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
- Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
- Provides contractor oversight and Identifies, deploys and manages resources
- Exhibits competent collaboration, conflict-resolution, and influencing skills
- Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
- PhD in life sciences (or other related field) with a minimum of 3 years of experience related to medical writing, or Masters in life sciences (or other related field) with a minimum of 6 years of experience, excellent English, both written and spoken.
- Considered a capable manager with regulatory medical writing expertise.
- Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards
- Excellent organizational/planning and problem-solving skills at the product level
- Works successfully with an intermittent level of direct supervision and knowledge of global regulations and guidelines for document submissions
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